Herpes ZosterPhase 2NCT05856084
Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
A Phase 2 study testing Low dose Recombinant Herpes Zoster Vaccine (CHO cells) and High dose Recombinant Herpes Zoster Vaccine (CHO cells) in people with Herpes Zoster, run by MAXVAX Biotechnology Limited Liability Company at 1 site in China.
Trial summary
The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Low dose Recombinant Herpes Zoster Vaccine (CHO cells) and High dose Recombinant Herpes Zoster Vaccine (CHO cells)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 924 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2023to 10 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Permanent residents aged 30 years and above;
- Subjects voluntarily agree to participate in the study and signed an informed consent;
- Be able to participate in all scheduled visits and comply with the protocol requirements.
Who cannot join
- Axillary temperature>37.0℃;
- History of herpes zoster within 5 years before vaccination;
- Prior vaccination with chickenpox vaccine or herpes zoster vaccine;
- Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination;
- Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
- Receipt of immunoglobulin or intravenous immunoglobulin within 3 months before vaccination;
Show all 17Show fewer
- Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination;
- A known allergy to any components of the study vaccine (especially allergic to aminoglycoside antibiotics), or history of severe allergy to any previous vaccination;
- History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning, etc.) or mental illness and family history;
- Asplenia or functional asplenia, or splenectomy caused by any condition;
- Primary or secondary impairment of immune function or diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
- Receipt of immunosuppressive therapy within 3 months before vaccination (such as long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose), but inhaled, intra-articular and topical steroids are acceptable;
- Severe cardiovascular disease(eg. Pulmonary heart disease, Pulmonary Edema); Severe liver or kidney disease; or diabetes with complication;
- History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications;
- Abnormal blood pressure during physical examination before vaccination (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg);
- Current or history of alcohol and/or drug abuse;
- Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.
Trial locations and contacts
1 site in 1 country.
China1 site
Yanjin Center for Disease Control and Prevention
Xinxiang, Henan, 453200
About this study
Official title: A Phase II, Single Center, Randomized, Blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older.
Read the detailed description
The clinical trial will be a single-center, randomized, blind, controlled study in which two dose levels of vaccine will be tested in healthy adults aged 30 to 49 years and 50 years and older. A total of 924 participants will be enrolled, including 396 participants aged 30 to 49 years and 528 participants aged 50 years and older. Participants aged 30 to 49 years will be randomized into three subgroups (low dose vaccine group, high dose vaccine group and placebo group) in a 1:1:1 ratio. Participants aged 50 years and older will be randomized into four subgroups (low dose vaccine group, high dose vaccine group, Shingrix® group and placebo group) in a 1:1:1:1 ratio.
- Conditions
- Herpes Zoster
- Being tested
- Low dose Recombinant Herpes Zoster Vaccine (CHO cells), High dose Recombinant Herpes Zoster Vaccine (CHO cells), Positive control, Placebo
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose Recombinant Herpes Zoster Vaccine (CHO cells)Biological
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.
High dose Recombinant Herpes Zoster Vaccine (CHO cells)Biological
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.
Positive controlBiological
Also called Shingrix®
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
PlaceboBiological
Also called Normal Saline for injection
0.5 mL per dose, containing 4.5 mg sodium chloride.
| Study group | Role | What they receive |
|---|---|---|
| Low dose vaccine group in adults aged 30 to 49 years | Experimental | Participants aged 30 to 49 years will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Low dose Recombinant Herpes Zoster Vaccine (CHO cells) |
| High dose vaccine group in adults aged 30 to 49 years | Experimental | Participants aged 30 to 49 years will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: High dose Recombinant Herpes Zoster Vaccine (CHO cells) |
| Placebo group in adults aged 30 to 49 years | Placebo comparator | Participants aged 30 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Placebo |
| Low dose vaccine group in adults aged 50 years and older | Experimental | Participants aged 50 years and older will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Low dose Recombinant Herpes Zoster Vaccine (CHO cells) |
| High dose vaccine group in adults aged 50 years and older | Experimental | Participants aged 50 years and older will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: High dose Recombinant Herpes Zoster Vaccine (CHO cells) |
| Shingrix® group in adults aged 50 years and older | Active comparator | Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Positive control |
| Placebo group in adults aged 50 years and older | Placebo comparator | Participants aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean concentration (GMC) of anti-gE antibody
Measured by ELISA.
Measured: Month 1 after the last vaccination
Seropositivity rate of anti-gE antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Measured: Month 1 after the last vaccination
Seroresponse rate of anti-gE antibody
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Measured: Month 1 after the last vaccination
Geometric Mean Fold Rise (GMFR) of anti-gE antibody concentration
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Measured: Month 1 after the last vaccination
Four-fold increase rate of anti-gE antibody concentration
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Measured: Month 1 after the last vaccination
Cell-Mediated Immunity (CMI) response
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL-2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Measured: Month 1 after the last vaccination
Vaccine Response Rate (VRR)
VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
Measured: Month 1 after the last vaccination
The incidence and severity of adverse events
Incidence and severity of adverse events within 30 minutes after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Measured: Within 30 minutes after each vaccination
The incidence and severity of adverse events
Incidence and severity of adverse events within 7 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Measured: Within 7 days after each vaccination
The incidence and severity of adverse events
Incidence and severity of adverse events during Day 8 to 30 after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Measured: Day 8 to 30 after each vaccination
The incidence and severity of adverse events
Incidence and severity of adverse events within 30 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Measured: Within 30 days after each vaccination
Secondary outcomes (13)
The incidence of Serious Adverse Events
Incidence of Serious Adverse Events (SAEs) from the first vaccination to 12 months after the last vaccination.
Measured: From the first vaccination to 12 months after the last vaccination
Potential Immune-Mediated Diseases
Incidence of Potential Immune-Mediated Diseases (pIMDs) from the first vaccination to 12 months after the last vaccination.
Measured: From the first vaccination to 12 months after the last vaccination
Geometric mean concentration (GMC) of anti-VZV antibody
measured by ELISA.
Measured: Month 1 after the last vaccination
Seropositivity rate of anti-VZV antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Measured: Month 1 after the last vaccination
Seroresponse rate of anti-VZV antibody
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Measured: Month 1 after the last vaccination
Geometric Mean Fold Rise (GMFR) of anti-VZV antibody
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Measured: Month 1 after the last vaccination
Four-fold increase rate of anti-VZV antibody
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Measured: Month 1 after the last vaccination
Geometric mean concentration (GMC) of anti-gE antibody
measured by ELISA.
Measured: At 6, 12 and 24 months after the last vaccination
Seropositivity rate of anti-gE antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Measured: At 6, 12 and 24 months after the last vaccination
Geometric mean concentration (GMC) of anti-VZV antibody
measured by ELISA.
Measured: At 6, 12 and 24 months after the last vaccination
Seropositivity rate of anti-VZV antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Measured: At 6, 12 and 24 months after the last vaccination
Cell-Mediated Immunity (CMI) response
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL 2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Measured: At 6, 12 and 24 months after the last vaccination
Vaccine Response Rate (VRR)
VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
Measured: At 6, 12 and 24 months after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start7 May 2023
- Primary completion1 Sep 2025
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 924 participants (actual)
Sponsor and investigators
- Lead sponsor
- MAXVAX Biotechnology Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henan Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Yanxia Wang, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856084
- Sponsor's protocol ID
- MKKCT-100-002
- Status last verified
- Oct 2026
- First submitted
- 4 May 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Center, Randomized, Blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
- ClinicalTrials.gov ID
- NCT05856084
- Acronym / sponsor ID
- MKKCT-100-002
- Conditions
- Herpes Zoster
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 924 participants (actual)
- Lead sponsor
- MAXVAX Biotechnology Limited Liability CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Henan Center for Disease Control and Prevention
- Study start
- 7 May 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older.
Detailed description
The clinical trial will be a single-center, randomized, blind, controlled study in which two dose levels of vaccine will be tested in healthy adults aged 30 to 49 years and 50 years and older. A total of 924 participants will be enrolled, including 396 participants aged 30 to 49 years and 528 participants aged 50 years and older. Participants aged 30 to 49 years will be randomized into three subgroups (low dose vaccine group, high dose vaccine group and placebo group) in a 1:1:1 ratio. Participants aged 50 years and older will be randomized into four subgroups (low dose vaccine group, high dose vaccine group, Shingrix® group and placebo group) in a 1:1:1:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Low dose vaccine group in adults aged 30 to 49 years | Experimental | Biological: Low dose Recombinant Herpes Zoster Vaccine (CHO cells)Participants aged 30 to 49 years will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). |
| High dose vaccine group in adults aged 30 to 49 years | Experimental | Biological: High dose Recombinant Herpes Zoster Vaccine (CHO cells)Participants aged 30 to 49 years will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). |
| Placebo group in adults aged 30 to 49 years | Placebo comparator | Biological: PlaceboParticipants aged 30 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). |
| Low dose vaccine group in adults aged 50 years and older | Experimental | Biological: Low dose Recombinant Herpes Zoster Vaccine (CHO cells)Participants aged 50 years and older will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). |
| High dose vaccine group in adults aged 50 years and older | Experimental | Biological: High dose Recombinant Herpes Zoster Vaccine (CHO cells)Participants aged 50 years and older will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). |
| Shingrix® group in adults aged 50 years and older | Active comparator | Biological: Positive controlParticipants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM). |
| Placebo group in adults aged 50 years and older | Placebo comparator | Biological: PlaceboParticipants aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Permanent residents aged 30 years and above;
- Subjects voluntarily agree to participate in the study and signed an informed consent;
- Be able to participate in all scheduled visits and comply with the protocol requirements.
Key exclusion criteria (17 listed)
- Axillary temperature>37.0℃;
- History of herpes zoster within 5 years before vaccination;
- Prior vaccination with chickenpox vaccine or herpes zoster vaccine;
- Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination;
- Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose Recombinant Herpes Zoster Vaccine (CHO cells)0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105. | Biological | Low dose vaccine group in adults aged 30 to 49 years, Low dose vaccine group in adults aged 50 years and older |
| High dose Recombinant Herpes Zoster Vaccine (CHO cells)0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105. | Biological | High dose vaccine group in adults aged 30 to 49 years, High dose vaccine group in adults aged 50 years and older |
| Positive controlAlso: Shingrix®0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B. | Biological | Shingrix® group in adults aged 50 years and older |
| PlaceboAlso: Normal Saline for injection0.5 mL per dose, containing 4.5 mg sodium chloride. | Biological | Placebo group in adults aged 30 to 49 years, Placebo group in adults aged 50 years and older |
Primary outcome
Geometric mean concentration (GMC) of anti-gE antibody
Time frame: Month 1 after the last vaccination
Measured by ELISA.
Seropositivity rate of anti-gE antibody
Time frame: Month 1 after the last vaccination
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Seroresponse rate of anti-gE antibody
Time frame: Month 1 after the last vaccination
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Geometric Mean Fold Rise (GMFR) of anti-gE antibody concentration
Time frame: Month 1 after the last vaccination
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Four-fold increase rate of anti-gE antibody concentration
Time frame: Month 1 after the last vaccination
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Cell-Mediated Immunity (CMI) response
Time frame: Month 1 after the last vaccination
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL-2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Vaccine Response Rate (VRR)
Time frame: Month 1 after the last vaccination
VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
The incidence and severity of adverse events
Time frame: Within 30 minutes after each vaccination
Incidence and severity of adverse events within 30 minutes after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
The incidence and severity of adverse events
Time frame: Within 7 days after each vaccination
Incidence and severity of adverse events within 7 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
The incidence and severity of adverse events
Time frame: Day 8 to 30 after each vaccination
Incidence and severity of adverse events during Day 8 to 30 after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
The incidence and severity of adverse events
Time frame: Within 30 days after each vaccination
Incidence and severity of adverse events within 30 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
13 secondary outcomes
The incidence of Serious Adverse Events
Time frame: From the first vaccination to 12 months after the last vaccination
Potential Immune-Mediated Diseases
Time frame: From the first vaccination to 12 months after the last vaccination
Geometric mean concentration (GMC) of anti-VZV antibody
Time frame: Month 1 after the last vaccination
Seropositivity rate of anti-VZV antibody
Time frame: Month 1 after the last vaccination
Seroresponse rate of anti-VZV antibody
Time frame: Month 1 after the last vaccination
Geometric Mean Fold Rise (GMFR) of anti-VZV antibody
Time frame: Month 1 after the last vaccination
Four-fold increase rate of anti-VZV antibody
Time frame: Month 1 after the last vaccination
Geometric mean concentration (GMC) of anti-gE antibody
Time frame: At 6, 12 and 24 months after the last vaccination
Seropositivity rate of anti-gE antibody
Time frame: At 6, 12 and 24 months after the last vaccination
Geometric mean concentration (GMC) of anti-VZV antibody
Time frame: At 6, 12 and 24 months after the last vaccination
Seropositivity rate of anti-VZV antibody
Time frame: At 6, 12 and 24 months after the last vaccination
Cell-Mediated Immunity (CMI) response
Time frame: At 6, 12 and 24 months after the last vaccination
Vaccine Response Rate (VRR)
Time frame: At 6, 12 and 24 months after the last vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanxia Wang principal investigator
Henan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose Recombinant Herpes Zoster Vaccine (CHO cells) and High dose Recombinant Herpes Zoster Vaccine (CHO cells) in people with Herpes Zoster, run by MAXVAX Biotechnology Limited Liability Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean concentration (GMC) of anti-gE antibody (time frame: Month 1 after the last vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.